Morbid ObesityNCT03159130
OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients
An observational study of Morbid Obesity, run by William Beaumont Army Medical Center at 1 site in United States.
Trial summary
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbid Obesity
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing a gastric sleeve procedure will be offered the opportunity to participate.
Who may be able to join
- Meets criteria for Bariatric surgery
- Consents to be in protocol
- No local anesthetic allergy
- Will be having sleeve gastrectomy
- Doesn't have extensive scarring of abdominal wall that would prevent placement of OnQ catheter
Who cannot join
- declines to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Army Medical Center
El Paso, Texas, 79920
About this study
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.
Read the detailed description
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population. Approximately 12 to 15 weight reduction surgeries are performed at William Beaumont Army Medical Center each month. It is the current practice that each patient receiving the laparoscopic gastric sleeve or laparoscopic Roux-en-Y gastric bypass receive an OnQ pain catheter during the surgery to reduce post-operative pain. There have been limited studies to quantify the efficacy of these devices. This study will seek to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.
- Conditions
- Morbid Obesity
- Keywords
- Pain pump catheters, bariatric surgery, OnQ pump, sleeve gastrectomy, continuous infusion catheter
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| receiving lidocaine | Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of 1% lidocaine. | |
| receiving injectable saline | Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of injectable saline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic use
immediate post-operative narcotic use per patient
Measured: from admission to recovery room until discharge from the hospital (3-5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startJun 2012 (estimated)
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: PI dropped the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Beaumont Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gregory Peirce, MD, Principal investigator, William Beaumont Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159130
- Sponsor's protocol ID
- 371884-1
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients
- ClinicalTrials.gov ID
- NCT03159130
- Acronym / sponsor ID
- 371884-1
- Conditions
- Morbid Obesity
- Keywords
- Pain pump catheters, bariatric surgery, OnQ pump, sleeve gastrectomy, continuous infusion catheter
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI dropped the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- William Beaumont Army Medical CenterUS federal agency
- Study start
- Jun 2012 (estimated)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.
Detailed description
This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population. Approximately 12 to 15 weight reduction surgeries are performed at William Beaumont Army Medical Center each month. It is the current practice that each patient receiving the laparoscopic gastric sleeve or laparoscopic Roux-en-Y gastric bypass receive an OnQ pain catheter during the surgery to reduce post-operative pain. There have been limited studies to quantify the efficacy of these devices. This study will seek to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receiving lidocaine | – | –Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of 1% lidocaine. |
| receiving injectable saline | – | –Each patient will receive an OnQ pain pump intra-operatively, with attachment to two OnQ catheters inserted on the lateral sides of the abdomen. Each catheter will be infused with 15 cc of injectable saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a gastric sleeve procedure will be offered the opportunity to participate.
Key inclusion criteria (5 listed)
- Meets criteria for Bariatric surgery
- Consents to be in protocol
- No local anesthetic allergy
- Will be having sleeve gastrectomy
- Doesn't have extensive scarring of abdominal wall that would prevent placement of OnQ catheter
Key exclusion criteria (1 listed)
- declines to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Narcotic use
Time frame: from admission to recovery room until discharge from the hospital (3-5 days)
immediate post-operative narcotic use per patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Peirce, MD principal investigator
William Beaumont Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by William Beaumont Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic use (time frame: from admission to recovery room until discharge from the hospital (3-5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.